Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of resistance exercise training in patients with pompe disease.

Conditions: Pompe Disease; Muscle Weakness

Summary: the purpose of this research study is to determine if exercise will help improve muscle strength, endurance, and quality of life in individuals with pompe disease. this is a research study to further define the outcome of patients with pompe disease treated with a combined diet and exercise therapy.

eligibility: subjects that are age 16 years or older, have been diagnosed with pompe disease by genetic testing, and are showing symptoms such as muscle weakness time commitment: the study will last for 8 months. this study consists of a baseline visit of and return visits at week 9, week 16, week 24, and week 32. at the week 9 visit the subject will be given an individualized exercise plan which will be carried out over the next 24 weeks. the subject will be asked to return for three more visits at week16, week 24 and week 32. the 24 week training period will involve 3 workouts a week approximately 15-30 minutes each. it will also involve a breathing exercise that the subject can do at home twice daily for 10-15 minutes per session. the study visits will include the exercise plan, physical exam, blood draw and questionnaires. anticipated benefits: the possible benefits include a delay in progression of muscle weakness. the knowledge gained from this study will help researchers understand the effect of exercise on the disease. this may eventually lead to new forms of prevention of symptom onset in the future.

Eligibility criteria:
inclusion criteria: 1. able to fully consent to the protocol. 2. physically able to perform resistance exercises for 12 weeks. 3. patients with a confirmed diagnosis of pompe disease. 4. age 16 years to 75 years. 5. currently receiving ert. 6. patient on ert for at least 1year. exclusion criteria: 1. patients with no confirmed diagnosis of pompe disease, either by gaa enzyme deficiency from any tissue and/or molecular testing revealing two gaa gene mutations 2. unable to walk or cycle 3. unable to consent to the study/ procedures 4. women who are pregnant or breastfeeding 5. heart disease 6. patients with any metal inside their body such as metallic clips used for vascular repairs and/or implanted devices such as cardiac pacemakers which would prevent them from doing the mri.

Keywords: exercise pompe disease pompe
assessment of flow in cerebrospinal fluid shunts with a second generation wireless thermal anisotropy measurement device

Conditions: Hydrocephalus

Summary: this study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing csf shunt flow. patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in csf shunts as confirmed by surgical outcomes at 7 days. if successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.


Eligibility criteria:
inclusion criteria: 1. existing ventriculoperitoneal csf shunt on which the subject is dependent 2. at least one symptom of shunt malfunction as determined by the investigator, such as but not limited to seizure, fever, headache, vision problems, dizziness, disorientation, confusion, vomiting, lethargy, irritability, difficulty waking or staying awake, swelling along shunt tract, enlargement of head, loss of balance, gait disturbance, and loss of sensory or motor function 3. exhibit shunt malfunction symptom(s) requiring surgical shunt revision per standard of care assessment without use of device data 4. region of intact skin overlying an unambiguously identifiable chronically indwelling ventricular shunt which crosses the clavicle and is appropriate in size for application of the study device 5. available for follow-up for up to seven days 6. signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) exclusion criteria: 1. presence of more than one distal shunt catheter in the study device measurement region 2. presence of an interfering open wound or edema in the study device measurement area 3. subject-reported history of adverse skin reactions to adhesives 4. investigator judges that the subject is likely to be lost to follow-up due to unavailability or clinical outcome being unobtainable 5. participation in the study will interfere with, or be detrimental to, administration of optimal health-care to the subject 6. previous participation in a rhaeos clinical study in which flowsense device measurement data were acquired 7. participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
exercise for physical health in men with prostate cancer

Conditions: Prostatic Neoplasm; Osteoporosis

Summary: the purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength and impact exercise training to flexibility/relaxation training on body composition (bone, muscle and fat mass), physical function (strength, gait, power, balance and self-report physical function and symptoms) in men currently treated with hormone therapy for prostate cancer.

prostate cancer survivors with advanced disease are commonly treated with androgen deprivation therapy (adt) to reduce testosterone. serious side effects of adt are rapid bone and muscle loss that can lead to osteoporosis and declines in neuromuscular function (strength, power, gait and balance) which increases the risk of fracture and falls (a risk factor for fracture) and impairs physical function. men on adt are 1.4 times more likely to fracture compared with their cancer-free peers and those who fracture have a poorer prognosis than those who do not. self-report physical function is also lower among men on adt. exercise can prevent bone loss, neuromuscular declines and falls in several populations. however, the ability of exercise to prevent bone loss from adt has not been tested, while data on exercise and neuromuscular function (strength only) in this population are limited to one published trial. the long-term goal of our research is to improve musculoskeletal health and function in cancer survivors. critical first steps to meet this goal are to determine whether our previously tested program of impact and resistance exercise, shown to improve bone health and neuromuscular function in women, can prevent bone loss and neuromuscular declines in prostate cancer survivors on adt. based on our previous research, we have developed the prevent osteoporosis with impact + resistance (powir) program to be adapted to clinical populations at risk for bone loss and declines in neuromuscular function. potentially, powir could mitigate bone and muscle losses from adt, and thereby lower fracture risk and improve quality of life.

Eligibility criteria:
inclusion criteria: * histologically confirmed prostate cancer * presently receiving or planning to begin androgen deprivation therapy for prostate cancer exclusion criteria: * presence of bone metastases in the proximal femur and lumbar spine * clinically defined osteoporosis * current or previous use of medications known to affect bone metabolism * current regular participation (\>2x/wk for at least 30 min/session) in a planned session of moderate-vigorous impact or resistance training * a medical condition, disorder, or medication that contraindicates participation in moderate intensity impact or resistance exercise

Keywords: randomized clinical trial elderly cancer survivor bone health body composition signs and symptoms androgen deprivation therapy
clean frontline: a stepped wedge cluster trial

Conditions: Hospital Infections; Environment, Controlled; Infection Control

Summary: environmental hygiene is a key component of infection prevention in healthcare, and a driver of healthcare associated infections. staff who clean in many low resource countries receive no formal training on cleaning, waste disposal and linen handling. this issue has been execrated by the covid-19 pandemic. the only recommended training on environmental hygiene for low resourced facilities, teach clean, uses a training of trainers model. a selected cadre "champions" which in turn train their peers with responsibilities on environmental hygiene at the facility level. early pilot data to test its effectiveness of this training package are very promising. the main objective is to evaluate the effectiveness of an environmental cleaning bundle to improve microbiological cleanliness in cambodian hospitals. the latest teach clean will be implemented across all hospitals (13) of three provinces in cambodia. a stepped wedge randomised trial will be used to evaluate the effectiveness of teach clean to improve microbiological cleanliness in cambodian hospitals. all facilities will receive the intervention. hospitals are arranged in groups of three or four based on the randomisation with staggered commencement dates of the intervention at four distinct time points. the design will include ten months of data collection. we expect one month gap between the training of champions and the training of staff at the facility level. the main outcome is microbiological cleanliness (\<2.5 cfu/cm2 = clean ; ≥2.5 cfu/cm2 = not clean) measured using a non-specific agar on one side for measuring total aerobic colony counts (acc/cm2). with 30 sampling sites in each hospital and with a pre-training cleanliness proportion ranging from 30% to 50% will give us over 85% power to detect a 10% absolute post-intervention increase in cleanliness. evidence from this trial will contribute to future policy and practice guidelines about hospital environmental hygiene and ultimately reduce healthcare associated infections. this would be the first randomised trial on environmental hygiene in low resource settings.


Eligibility criteria:
inclusion criteria for surfaces sites selected for primary outcome measurement * surfaces within the patient zone which frequently touched surfaces of the targeted wards: maternity, pediatric and general medicine exclusion criteria: * surfaces outside the patient zone * surfaces not in the wards of interest
24-hour intraocular pressure with brinzolamide/timolol versus brimonidine/timolol

Conditions: Glaucoma

Summary: the proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. this comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. the design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.


Eligibility criteria:
inclusion criteria: * patient has open-angle glaucoma and is older than 29 years * patients should exhibit typical disc, or field changes and an untreated morning iop greater than 25 mm hg * patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning iop reduction * patient deemed by pi to require adjunctive therapy to obtain desired target iop * patient should exhibit iop greater than 18 mm hg on travoprost monotherapy (2 separate iop readings at 10:00) * patient has mild to moderate glaucoma (field loss more than 16 db; cupping 0.8 or less) * distance best corrected snellen visual acuity at least 0.1 * no contraindications to travoprost, brimonidine, brinzolamide and β-blockers * no history of lack of response (\<10% morning iop reduction) to any medication * patient can understand the instructions and adhere to medications exclusion criteria: * female patient of childbearing potential or lactating mother * history of trauma, inflammation, surgery * history of past use of steroids (within 2 months), severe dry eyes and use of contact lenses * signs of ocular infection, except blepharitis * evidence of corneal abnormality that may affect iop measurements etc * closed angle * history of non-compliance

Keywords: 24-hour iop control brinzolamide/timolol brimonidine/timolol travoprost
a study comparing the safety and efficacy of two dosing regimens of abt-874 to placebo in subjects with moderate to severe chronic plaque psoriasis

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to determine the safety and efficacy of 2 doses of abt-874 versus placebo in the treatment of subjects with moderate to severe plaque psoriasis.


Eligibility criteria:
inclusion criteria: * subject is \>= 18 years of age * subject had a clinical diagnosis of psoriasis for at least 6 months, and had moderate to severe plaque psoriasis * subject is judged to be in generally good health as determined by the principal investigator exclusion criteria: * subject has previous exposure to systemic anti-il 12 therapy * subject cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot avoid uvb or puva phototherapy * subject is taking or requires oral or injectible corticosteroids * subject diagnosed with erythrodermic psoriasis, pustular psoriasis, medication-induced or medication-exacerbated psoriasis or new onset guttate psoriasis * subject considered by the investigator, for any reason, to be an unsuitable candidate * female subject who is pregnant or breast-feeding or considering becoming pregnant

Keywords: plaque psoriasis
cost-effectiveness study of mirview™ mets in patients with cancer of unknown primary (cup)

Conditions: Neoplasms, Unknown Primary

Summary: the aim of the study is in cancer of unknown primary (cup) patients, to compare the cost-effectiveness of mirview™ mets test with conventional work-up in identifying the primary tumor site.

thousands of patients are diagnosed each year with metastatic cancer; however, about 3-5% of them are diagnosed with cancer of unknown primary (cup). in order to identify the optimal treatment plan for individual patients with cup, the primary tumor site must be identified. patients undergo a wide range of costly, time-consuming, and inefficient tests to identify the primary site of origin, often to no avail. in this era of targeted therapies, the accurate diagnosis of the primary tumor can be crucial. mirview™ mets is a new molecular diagnostic tool that identifies the tissue-of-origin of metastatic tumors, with 90% sensitivity.

Eligibility criteria:
inclusion criteria: 1. patients who present with histologically-confirmed metastatic cancer in whom an initial work-up which consists of detailed medical history, physical examination, basic laboratory studies, histopathological review of biopsy material, and ct scan of the chest abdomen and pelvis fail to identify the primary site. 2. older than 18 years 3. performance status \<2 4. life expectancy \>3 months 5. anc \>1500 6. platelets \>100,000 if bone marrow is not involved 7. hb \> 9 8. creatinine \<2 9. lfts \< x5 normal 10. histology proven of malignancy 11. enough material for mirview test (10 slices of 10 micrometer sections) 12. member of clalit hmo exclusion criteria: 1. patients unable or unwilling to sign the informed consent form 2. under 18 years old 3. performance status \>2 4. life expectancy\<3 months 5. anc \<1500 6. platelets \<100,000 if marrow not involved 7. hb \< 9 8. creatinine \>2 9. lfts \> x5 normal 10. not member of clalit hmo

Keywords: cancer of unknown primary site (cup)
multi-site cohort study for the development of personalized pharmacotherapy in patients with tuberculosis (tb)

Conditions: Tuberculosis; Latent Tuberculosis; Nontuberculous Mycobacterium Infection

Summary: based on the collected antibiotic concentration data and individual patient's clinical information, a pharmacokinetic analysis report that can be applied for dose adjustment of the individual patient is provided. the pharmacokinetic/pharmacodynamic index using the minimum inhibition concentration (mic) of the antibiotic obtained from the patient's clinical isolate is also explored. utilizing these, we intend to establish a population pharmacokinetic model of antibiotics prescribed in treating tuberculosis and nontuberculous mycobacteria (ntm). the developed population pharmacokinetic model can be applied for therapeutic drug monitoring (tdm) based on dose adjustment through the obtained pharmacokinetic parameters.


Eligibility criteria:
inclusion criteria: * patients diagnosed with tuberculosis. * latent tuberculosis, or nontuberculous mycobacteria (ntm) disease and currently under treatment with antibiotic drugs. * patients who understand and voluntarily sign an informed consent form before any study-related procedures are conducted. exclusion criteria: - children (minors) for whom the consent of a legal representative is impossible.

Keywords: tb latent tuberculosis infection (ltbi) ntm
two-session catheter-directed sclerotherapy using ethanol for endometrioma

Conditions: Sclerotherapy; Endometrioma

Summary: the goal of this clinical trial is to evaluate the safety and clinical outcomes of two-session catheter-directed sclerotherapy (cds) with 96% ethanol in patients with endometrioma. the main question it aims to answer is: • is two-session cds with 96% ethanol safe and effective for treating endometrioma? participants will: * receive the first session cds for endometrioma * carry the catheter overnight and be monitored in the patient ward * receive the second session cds the next day

catheter-directed sclerotherapy has been reported as an effective treatment for endometrioma. however, whether the sclerosing agent should be retained inside the endometrioma was controversial. to increase the contact between the sclerosing agent and the endometrioma wall, two-session catheter-directed sclerotherapy using 96% ethanol was attempted, and safety and clinical outcomes were assessed in patients with endometrioma.

Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * symptom manifestation as endometriosis (i.e., dysmenorrhea, dyspareunia, and lower abdominal or pelvic pain) * endometrioma ≥ 3 cm confirmed on ultrasound * no evidence of solid lesions on ultrasound * no suspected extraovarian endometriosis exclusion criteria: * history of gynecologic malignancy * active inflammation or infection * abnormal coagulation profile * loss to follow-up
long-term safety, tolerability and efficacy of omalizumab in japanese children

Conditions: Allergic Asthma

Summary: the purpose of this extension study is to assess the long-term safety and tolerability of omalizumab as an add-on therapy in japanese pediatric patients (6 to 15 years of age) with inadequately controlled allergic asthma despite current recommended treatment by providing continued treatment with omalizumab to patients who have previously completed the core study.


Eligibility criteria:
inclusion criteria: * patients who completed the core study (ige025b1301) and who in the investigator's clinical judgment could benefit from continuous treatment of the study drug. exclusion criteria: * patients who currently have diagnosed cancer, are currently being investigated for possible cancer or have any history of cancer. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means; using a highly effective method of birth control; or agreeing on total abstinence and the investigator also judges that the age, career lifestyle or sexual orientation of the patient ensures compliance. * with clinically significant uncontrolled systemic disease (eg: infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, cerebro-vascular, endocrinologic or gastrointestinal disease) after the treatment period of the core study. * patients with a history of major protocol violations during the core study and who are considered potentially unreliable as judged by the investigator at each site.

Keywords: omalizumab allergic asthma pediatric patients
can drospirenone be used to prevent lh surge in controlled ovarian stimulation in pcos?!

Conditions: PCOS (Polycystic Ovary Syndrome)

Summary: the goal of this clinical trial is to learn if drospirenone can work to prevent lh surge in controlled ovarian stimulation in pcos cases undergoing art cycles. the main questions it aims to answer are: can drospirenone prevent lh surge in controlled ovarian stimulation in pcos cases ? can it prevent the occurance of ovarian hyperstimulation? researchers will compare drospirenone to cetrorelix (a well known drug for such cases) to see if drospirenone works the same way. participants will: take drospirenone or cetrorelix from stimulation day 5 ( 5 days of ovarian stimulation) till day of hcg trigger - monitoring will be done before the cycle and through the cycles with vaginal ultrasound assessment and lab testing

the goal of this novel clinical trial is to study if drospirenone can work to prevent lh surge in controlled ovarian stimulation in pcos cases undergoing art cycles in comparison to a gold standard drug cetrorelix: all pcos cases: 50 case in this novel trial. 25 in each group will be randomized after taking 5 days of ovarian stimulation to either drospirenone tablet/d or cetrorelix injection/d till the day of hcg. at the day of hcg, lab testing will be done in addition to ultrasound assessment by transvaginal probe. the tests are: progesterone, e2, lh. assesment will be done for the number quality of follicles and the number quality of embryos developed, development of ohss, vitrification/thawing of embryos after 1 month then the clinical and chemical pregnancy rate.

Eligibility criteria:
inclusion criteria: * pcos was diagnosed according to the rotterdam consensus criteria (two out of three of the following criteria): 1. oligo- or anovulation 2. clinical and/or biochemical signs of hyperandrogenism 3. polycystic ovaries). * a diagnosis of congenital adrenal hyperplasia, cushing's syndrome, androgen-producing tumours, hyperprolactinemia and thyroid dysfunction were all rulled out. exclusion criteria: * age 38 years * basal fsh level 12 miu/ml * previous ovarian surgery * congenital uterine anomaly anomaly, intrauterine adhesion and male partner with non-obstructive azoospermia.

Keywords: pcos ppos drospirenone gn antagonist
cognitive effects of tdcs and trns in schizophrenia

Conditions: Schizophrenia; Cognitive Impairment

Summary: the purpose of this study is to investigate the cognitive effects of different electrical stimulation modalities, such as transcranial direct and random-noise stimulation over the dorsolateral prefrontal cortex, in schizophrenia.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia based on diagnostic and statistical manual (dsm)5 * being 18-50 years old (male and female) * if female, negative urine pregnancy test * feasibility for tdcs/trns interventions according to safety guidelines * stable medication regime, especially for classical neuroleptics and all central nervous system activating medications, if taken, 4-6 weeks before the experiment * fluency in the native language * right-handed * required written informed consent signed by patients' guardian exclusion criteria: * pregnancy * alcohol or substance dependence * comorbid bipolar disorder and mood disorder * history of seizure * history of neurological disorder * history of head injury * presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)